60 Participants Needed

BLT vs Lidocaine for Procedural Pain

NA
Overseen ByNardin Awad, DO
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective for this pilot study is to evaluate the efficacy of the compounded topical anesthetic Benzocaine 20%/ Lidocaine 8%/Tetracaine 4% (BLT) compared to 4% Lidocaine topical in providing relief of pain during IPL, PDL, and microneedling procedures.

Will I have to stop taking my current medications?

The trial requires that you stop taking anxiolytics (medications for anxiety) or opiates (pain medications) as they may interfere with the study results.

Is the combination of lidocaine, benzocaine, and tetracaine safe for use in humans?

Research shows that lidocaine and tetracaine creams are generally safe for use in humans, with mild side effects. Studies on lidocaine creams, like LMX4, found no significant toxicity even when used in moderate amounts for cosmetic procedures.12345

What makes the BLT drug unique for procedural pain?

The BLT drug, which combines benzocaine, lidocaine, and tetracaine, is unique because it offers a combination of three anesthetics that can provide effective pain relief with a shorter application time compared to some other topical anesthetics. This makes it particularly useful for quick procedures, as it can reduce waiting time for pain relief to take effect.12367

What data supports the effectiveness of the drug BLT (Benzocaine/Lidocaine/Tetracaine) for procedural pain?

Research shows that a cream containing lidocaine and tetracaine is effective in reducing pain during dermatologic procedures, such as laser treatments, and is associated with mild side effects. This suggests that the combination of these anesthetics in BLT could also be effective for procedural pain.12378

Who Is on the Research Team?

BJ

Brian J Simmons, MD

Principal Investigator

Dartmouth Health

Are You a Good Fit for This Trial?

This trial is for individuals experiencing pain during specific skin procedures like IPL (intense pulsed light), PDL (pulsed dye laser), and microneedling. Details on who can join or reasons for exclusion are not provided.

Inclusion Criteria

I regularly see a dermatologist for skin treatments like IPL, PDL, or microneedling.

Exclusion Criteria

I am currently taking anxiety medication or painkillers.
I am currently pregnant or breastfeeding.
I am being treated for a skin condition that could affect this study's evaluation.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical anesthetics (BLT and Lidocaine) applied to the face prior to IPL, PDL, and microneedling procedures

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain relief effectiveness immediately after treatment

1 day

What Are the Treatments Tested in This Trial?

Interventions

  • BLT
  • Lidocaine topical
Trial Overview The study aims to compare the effectiveness of a compounded anesthetic cream called BLT (Benzocaine/Lidocaine/Tetracaine) with a standard 4% Lidocaine cream in reducing pain from certain dermatological procedures.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Left Side LidocaineExperimental Treatment2 Interventions
Group II: Left Side BLTExperimental Treatment2 Interventions

BLT is already approved in United States, Canada for the following indications:

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Approved in United States as BLT for:
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Approved in Canada as BLT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

Published Research Related to This Trial

The FDA-approved lidocaine and tetracaine topical anesthetic cream (Pliaglis®) is both safe and effective for managing pain during various dermatologic laser procedures, including laser resurfacing and hair removal.
Dermatologists should consider using LT cream as a preferred option for topical anesthesia to enhance patient comfort and satisfaction during these procedures.
Pain management with a topical lidocaine and tetracaine 7%/7% cream with laser dermatologic procedures.Cohen, JL.[2013]
Lidocaine/tetracaine cream (Pliaglis) is a newer topical anesthetic that effectively reduces pain during cosmetic dermatologic procedures, as shown in multiple clinical trials.
This combination anesthetic is favored for its ease of use and mild side effects compared to other topical anesthetics, making it a safe option for patients.
Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures.Alster, T.[2021]
In a study involving 40 subjects undergoing superficial dermatosurgical procedures, the combination cream of 7% lignocaine and 7% tetracaine provided significantly better pain relief compared to the 2.5% lidocaine and 2.5% prilocaine cream, as measured by visual analogue scale scores.
The findings suggest that the lignocaine/tetracaine combination is an effective topical anesthetic for short-term use (30 minutes), allowing for quicker onset of analgesia and potentially improving the efficiency of dermatological procedures.
Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine.Gahalaut, P., Mishra, N., Chauhan, S., et al.[2021]

Citations

Pain management with a topical lidocaine and tetracaine 7%/7% cream with laser dermatologic procedures. [2013]
Review of lidocaine/tetracaine cream as a topical anesthetic for dermatologic laser procedures. [2021]
Comparison of Topical Anesthetics for Radiofrequency Ablation of Achrocordons: Eutectic Mixture of Lignocaine/Prilocaine versus Lidocaine/Tetracaine. [2021]
Tetracaine versus lidocaine-prilocaine for preventing venipuncture-induced pain in children. [2019]
Efficacy of lidocaine 7 %, tetracaine 7 % self-occlusive cream in reducing MAL-cPDT-associated pain in subjects with actinic keratosis: A randomized, single-blind, vehicle-controlled trial (The "3P-Trial"). [2021]
The use of compound topical anesthetics: a review. [2019]
Safety of occluded 4% liposomal lidocaine cream. [2013]
Comparative Evaluation of Two Different Topical Anesthetic Agents in Controlling Pain during Intraoral Local Anesthetic Administration in Children: A Split-mouth Triple-blinded Randomized Clinical Trial. [2022]
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